MECLIZINE HYDROCHLORIDE

Product NDC
63629-2432
11-digit product format
636292432
Labeler code
63629
Product ID
63629-2432_95ff1d32-94ad-4ef2-81b1-eff43157df3f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meclizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040659
Marketing category
ANDA
Marketing start
2010-06-04
Marketing end
2026-10-31
Substance
MECLIZINE HYDROCHLORIDE
Active strength
12.5 mg/1
Pharmacologic classes
Antiemetic [EPC], Emesis Suppression [PE]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MECLIZINE HYDROCHLORIDE

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MECLIZINE HYDROCHLORIDE12.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHDP7W44CIO
Rxcui995624

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-2432-1MECLIZINE HYDROCHLORIDE1000 in 1 BOTTLETABLET1000103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2432-1EA - Each63629-24320ccd2cd5-db64-41c2-b1db-260f2bbf7c5812021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2432MECLIZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 1 package rows20231208_6c66ee38-10bb-4559-9d2f-51e6d6f091ee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
995624meclizine HCl 12.5 MG Oral TabletPSN6c66ee38-10bb-4559-9d2f-51e6d6f091ee103
995624meclizine hydrochloride 12.5 MG Oral TabletSCD6c66ee38-10bb-4559-9d2f-51e6d6f091ee103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2432-1636292432011000 TABLET in 1 BOTTLE (63629-2432-1) 1000 tablet2021-02-252026-10-31NoNoCurrent